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Case Study - Simbec Research Limited specialize in drug development, clinical pharmacology and the development of bio-analytical methods for drugs

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Introduction

Sam McHugh Ysgol Gyfun Emlyn Simbec Research Limited Background Simbec are one of the longest established Clinical Research Organisations (CRO) in Europe, who carry out Phase I - IV clinical research. They are a multi-national company with offices overseas in Israel, Spain, Japan, India and Eastern Europe. They specialize in drug development, clinical pharmacology and the development of bio-analytical methods for drugs. In Merthyr Tydfil they have bio-analytical, gammascintography, pathology labs and also a ward for volunteers on trials. Monday 8th July - Day 1 After an early morning, and an hour long train journey from Cardiff to Merthyr Tydfil, we (me and Emma, who was also on a quality work placement) arrived at Simbec. On arrival at the reception we were greeted by the company secretary Brian Hallisey. In a thirty minute talk he went through the basic safety procedures, we were also given the opportunity to ask him any questions we had at that point. He then took us down to the bio-analytical unit, where we would be spending the first three days of our visit. Brian Hallisey then introduced us to Philip R. Robinson, the manager of the bio-analytical unit. He explained Simbec's position as a CRO who carry out trials and analysis into drugs, to help fast track their development. ...read more.

Middle

Wednesday 10th July - Day 3 This morning we received the results from our experiment the day before. Surprisingly we all did remarkably well, resulting in us receiving many job offers in place of the existing staff. As a permanent memento of this experiment we each received the printout of all our results, which included several graphs and tables. Having gone through the solid phase extraction process we were shown a liquid phase extraction, the difference between the two being obvious. With these extraction processes no two are the same for two different drugs, which means for every assay a new method has to be devised. In this case the process involved fifteen steps, all of which have to be followed very closely to ensure accurate reading at the end, although the addition of an internal standard (when a known amount of a known chemical is added, so at the end the ratio of it's original amount to the end amount is calculated and applied to the drug to get a true figure) solves this problem. Next on out agenda was a viewing with the GC/MS (Gas Chromatography/Mass Spectrometry), the difference to LC/MS being the samples are in the gas phase when analysed. The advantage of GC/MS is that the samples that are being analysed can be more volatile, but will not be lost. ...read more.

Conclusion

Friday 12th July - 5th Day For our final morning we took a trip to the drug dispensary, where the drugs for the Phase I studies were prepared. What struck me about this lab was that everything had to be immaculately clean, we had to wear some fetching hair nets and polythene shoe covers! Once the drug had been prepared for that day, we went to the ward to see the drugs being administered to the volunteers. The timing of everything had to be exactly right to the second, so if the drug was given at 11:23:34 and a blood sample had to be taken an hour later, it would have to be taken as close to 12:23:34 as possible. Unfortunately due to prior lunch engagements we were forced to leave early, we said our thanks and our goodbyes, and were driven to Cardiff. I had thoroughly enjoyed the placement and the week as a whole, it has certainly helped open my eyes a little. It was a great placement and I was fortunate to get this opportunity, especially with such a friendly organisation. Not only was the placement a very good experience, but living with other students was also of benefit to me, so I would like to take this opportunity to thank Business in the Community (Quality Placements Wales & London) for this unique opportunity - Thanks. ...read more.

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